β¨ Medicines Consent Notices
6 JUNE 2013 NEW ZEALAND GAZETTE, No. 72
1921
Medicines Act 1981
Consent to the Distribution of New Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Empliciti
- Active Ingredient: Dapagliflozin propanediol 12.3mg equivalent to dapagliflozin 10mg
- Dosage Form: Film coated tablet
- New Zealand Sponsor: AstraZeneca Limited
- Manufacturers: Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Bristol-Myers Squibb Company, Indiana, United States of America
Product: Juvicor
- Active Ingredients: Simvastatin 10mg
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg - Dosage Form: Film coated tablet
- New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
- Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Product: Juvicor
- Active Ingredients: Simvastatin 20mg
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg - Dosage Form: Film coated tablet
- New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
- Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Product: Juvicor
- Active Ingredients: Simvastatin 40mg
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg - Dosage Form: Film coated tablet
- New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
- Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Product: Oxytocin BNM
- Active Ingredient: Oxytocin 5IU/mL equivalent to 8.3mcg/ml
- Dosage Form: Solution for injection
- New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
- Manufacturer: Rotexmedica GmbH, Trittau, Germany
Product: Oxytocin BNM
- Active Ingredient: Oxytocin 10IU/mL equivalent to 16.6mcg/ml
- Dosage Form: Solution for injection
- New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
- Manufacturer: Rotexmedica GmbH, Trittau, Germany
Dated this 29th day of May 2013.
DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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Consent to the Distribution of New Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Herceptin
- Active Ingredient: Trastuzumab 150mg
- Dosage Form: Powder for infusion
- New Zealand Sponsor: Roche Products (NZ) Limited
- Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare29 May 2013
Medicines, Distribution, Consent, New Zealand, Pharmaceuticals
- Dr Stewart Jessamine, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Distribution, Consent, New Zealand, Pharmaceuticals
NZ Gazette 2013, No 72